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Carcinoma, Ovarian Epithelial clinical trials

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NCT ID: NCT05700669 Recruiting - Breast Cancer Clinical Trials

Study To Assess Safety And Efficacy Of AsiDNA In Combination With Olaparib In Participants With Recurrent Solid Tumors

Start date: February 20, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1b/2 open-label, multicenter, basket study to determine the safety, anti-tumor activity, tolerability, and pharmacokinetics /pharmacodynamics of AsiDNA in combination with olaparib in participants with recurrent epithelial ovarian cancer, breast cancer and metastatic castration-resistant prostate cancer who have progressed on previous Poly (ADP-ribose) polymerase (PARP) inhibitor therapy. The study will be conducted in two phases. The Phase 1b dose escalation study designed to establish the safety, tolerability, pharmacologically active doses/ maximum tolerated dose and/or recommended phase 2 dose of AsiDNA in combination with olaparib.

NCT ID: NCT05697601 Recruiting - Ovarian Cancer Clinical Trials

Predictors of Ovarian Cancer and Endometrial Cancer for Artificial-Intelligence-Based Screening Tools

Start date: February 28, 2023
Phase:
Study type: Observational

The goal of this observational study is to explore the possible associated factors of ovarian cancer and endometrial cancer in Indonesia and develop screening tools that could predict the risk of both types of cancer The specific objectives of the study are 1. Elaborating the situation of ovarian and endometrial cancer in Indonesia 2. Exploring the possible clinical, demography and laboratory predictors of these diseases 3. Develop artificial-intelligence-based screening tools for both type of cancer based on possible predictors This study will utilize the patient registry diagnosed with ovarian and endometrial cancer. We assumed that several demography, clinical, and laboratory predictors might possess good screening performance with higher sensitivity and specificity (>80%).

NCT ID: NCT05693987 Recruiting - Ovarian Cancer Clinical Trials

Early Detection of Ovarian Cancer Using Plasma Cell-free DNA Fragmentomics (Prospective Study)

Start date: November 1, 2022
Phase:
Study type: Observational

The purpose of this study is to enable non-invasive early detection of ovarian cancer in high-risk populations through the establishment of a multimodal machine learning model using plasma cell-free DNA fragmentomics. Plasma cell-free DNA from early stage ovarian cancer patients and healthy individuals will be subjected to whole-genome sequencing. Five diferent feature types, including Fragment Size Coverage (FSC), Fragment Size Distribution (FSD), EnD Motif (EDM), BreakPoint Motif (BPM), and Copy Number Variation (CNV) will be assessed to generate this model.

NCT ID: NCT05691504 Recruiting - Clinical trials for Recurrent Fallopian Tube Carcinoma

Testing the Combination of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers

Start date: September 14, 2023
Phase: Phase 1
Study type: Interventional

This phase I trial tests the safety, side effects, and best dose of combination therapy with pelcitoclax (APG-1252) and cobimetinib in treating patients with ovarian and endometrial cancers that have come back after a period of improvement (recurrent). APG-1252 is a drug that inhibits activity of proteins that prevent cell death, leading to increased cell death and reduced cell growth. Cobimetinib is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving APG-1252 in combination with cobimetinib may shrink or stabilize tumor in patients with recurrent ovarian and endometrial cancers.

NCT ID: NCT05659381 Recruiting - Clinical trials for Stage IV Ovarian Cancer

Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer

HOTT
Start date: March 8, 2024
Phase: Phase 3
Study type: Interventional

Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC (Arm A) will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (Arm B) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per institutional standard (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 2-3 cycles) for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing until progression or 36 months (if no evidence of disease).

NCT ID: NCT05636111 Recruiting - Ovarian Cancer Clinical Trials

Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer

Start date: July 12, 2023
Phase: Phase 1
Study type: Interventional

To learn if adding lurbinectedin to the combination of paclitaxel and bevacizumab can help to control advanced cancer.

NCT ID: NCT05633836 Recruiting - Ovarian Cancer Clinical Trials

MicroFluO: FLUorescence-guided Surgery for Ovarian Cancer

MicroFluO
Start date: May 2023
Phase: N/A
Study type: Interventional

Epithelial ovarian cancers (EOC) are discovered in 75% of cases at an advanced stage, marked by the presence of peritoneal carcinomatosis. It has been shown that one of the main prognostic factors is the achievement of a macroscopically complete cytoreductive surgery, i.e. without visible peritoneal metastasis at the end of the procedure. The prognosis of patients is inversely correlated to the tumor residue at the end of the procedure, and 60% of patients present a peritoneal recurrence within two years after the initial management. This suggests that microscopic peritoneal metastases may be present that are not eradicated by surgery and not controlled by systemic chemotherapy. Their presence could be involved in the mechanisms leading to the occurrence of peritoneal recurrence. The MicroPCI protocol (NCT03754569), showed that microscopic peritoneal metastases were present at the end of macroscopically complete surgery of advanced-stage EOC in 98.14% of cases.This naturally lead to the question of the impact of microscopic cytoreduction on the prognosis of patients. Fluorescence detection of peritoneal metastases after intravenous injection of indocyanine green (ICG) and their resection have already been evaluated with promising results in digestive and ovarian carcinomas. The objective of the MicroFluO protocol is to propose on the one hand a diagnostic time by fluorescence during the laparoscopic evaluation performed to define the resectability of the peritoneal carcinomatosis and also at the end of the macroscopically complete cytoreductive surgery to perform the biopsy of the fluorescent areas suspected of presenting residual microscopic peritoneal metastases. Patients diagnosed with peritoneal carcinomatosis undergo exploratory laparoscopy, during which lesion mapping is performed to assess the resectability of the lesions. A biopsy is performed during this procedure to confirm the histological diagnosis. An initial fluorescence mapping will be performed at this diagnostic time. Once cytoreductive surgery has been performed, intravenous injection of ICG is performed according to the manufacturer's recommendations. Peritoneal lesions emitting a fluorescent signal will be sampled. These samples will be studied in anatomopathology under the same conditions as the other surgical parts. No increase in morbidity is expected in relation to this study. The number of specimens taken is dependent on the peritoneal tumor burden.

NCT ID: NCT05622890 Recruiting - Clinical trials for Fallopian Tube Cancer

A Single-arm Clinical Trial of IMGN853 in Chinese Adult Patients With Platinum-resistant, Epithelial Ovarian Cancer

Start date: August 18, 2022
Phase: Phase 3
Study type: Interventional

This Phase III single-arm study is to evaluate the efficacy and safety of IMGN853 in Chinese adult patients with platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (hereafter referred to as PROC) with high FRĪ± expression.

NCT ID: NCT05620654 Recruiting - Ovarian Cancer Clinical Trials

A Phase I Dose-finding Trial of Hyperthermic Intraperitoneal Paclitaxel Combined With Cisplatin

Start date: December 1, 2022
Phase: Phase 1
Study type: Interventional

Primary objective of this trial is to identify the maximum tolerated dose (MTD) of paclitaxel combined with a fixed dose of cisplatin (75 mg/m2) delivered as hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with ovarian cancer. In this single-center Phase I trial, Bayesian Optimal Interval Design (TITE-BOIN) was used. The starting dose for paclitaxel was 175 mg/m2, with escalation in 25 mg/m2 increments until the MTD was determined or the maximum dose level of 225 mg/m2 was reached. The target dose-limiting toxicity (DLT) rate was 25%, and the total sample size was 30 patients.

NCT ID: NCT05620134 Recruiting - Cancer Clinical Trials

Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer

Start date: October 17, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of subcutaneously administered JK08 in patients with unresectable locally, advanced or metastatic cancer.